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Safety and Efficacy Trial to Treat Open-Angle Glaucoma or Ocular Hypertension

Ocular Hypertension Clinical Trial

Official title:
A Phase I/II Dose Escalation Safety and Efficacy Trial of DE-112 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension

Clinical Trial Summary

To investigate the safety and efficacy of DE-112 in lowering intraocular pressure in subjects with primary open-angle glaucoma or ocular hypertension.

Clinical Trial Description

This study will be conducted in two stages. Stage One is an open-label, adaptive dose-selection, safety and efficacy trial of up to four concentrations of DE-112 ophthalmic solution enrolling a total of 24 subjects.

Stage Two of the study is a randomized, double-masked, placebo- and active-controlled, parallel-group, multi-center trial comparing the efficacy and safety of two concentrations of DE-112 ophthalmic solution with placebo and timolol enrolling a total of 120 subjects. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01279083
Study type Interventional
Source Santen Inc.
Contact
Status Completed
Phase Phase 1/Phase 2
Start date January 2011
Completion date February 2012
View Details
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